Clinical Trial: Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Two-Phase, Double Blind, Placebo-Controlled, Randomized, Crossover Study of the Safety and Efficacy of Intra-Oral NH004 Films for the Short-Term Relief of Sialorrhea Sym
Brief Summary: The primary goal of the study is to evaluate the safety and potential efficacy of intra-oral dissolvable NH004 films to improve the short-term symptoms of sialorrhea (drooling) in Parkinson's disease (PD) patients.
Detailed Summary:
NH004 contains the anticholinergic agent tropicamide and is delivered in a convenient product form (intra-oral dissolvable thin films) designed for the management of sialorrhea. This study is a double blind, placebo-controlled, crossover study of the safety and potential efficacy of three doses of of NH004 films for the short-term relief of the symptoms of sialorrhea in Parkinson's disease patients.
A total of up to 36 Parkinson's disease patients will be enrolled in the study in two Phases. Phase A will include 12 patients and Phase B up to 24 patients. There will be an interim analysis after conclusion of Phase A. In both phases patients will be randomized into one of four groups. Each group will have a distinctive sequence for receiving intra-oral dissolvable films of 0.3 mg, 1 mg, 3 mg of NH004, or placebo during four visits.
Sponsor: NeuroHealing Pharmaceuticals Inc.
Current Primary Outcome: Sialorrhea Visual Analogue Scale (VAS) [ Time Frame: Before and 120 min after treatment administration ]
Original Primary Outcome: Phase A (first 12 patients): subjective sialorrhea visual-analog scale. Phase B: sialorrhea visual-analog scale and objective saliva measurement (measured with a cotton roll). [ Time Frame: Phase A: every 15 minutes for 2 hours. Phase B: same as Phase A + one objective saliva measurement at a time point to be determined in the interim analysis. ]
Current Secondary Outcome: Percentage Change in Saliva Volume [ Time Frame: Before and 75 minutes after treatment administration ]
Original Secondary Outcome:
Information By: NeuroHealing Pharmaceuticals Inc.
Dates:
Date Received: September 25, 2008
Date Started: March 2008
Date Completion:
Last Updated: September 22, 2015
Last Verified: April 2013